Course overview
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This e-Learning course is for individuals who need to conduct effective conformity, performance and effectiveness audits. It can also serve an essential bridging course for existing ISO 9001 Lead Auditors.
course is applicable to all ISO 9001-based sector standards
ISO 9001 – general manufacturing/service
AS9100 – aerospace and related defence
AS13100 – aeroengine suppliers
IATF 16949 – automotive and motorsport
AQAP 2110 & AQAP 2310 – defence (NATO/UK MOD) supply chain
IRIS (ISO 22163) – global rail supply chain
TEC have packaged everything needed into this practical e-Learning course to ensure that participants will feel confident to plan, prepare, perform and report the results of audits focused on ISO 9001-based sector-specific standards using a ‘process approach' and 'risk-based thinking’ – in the same way as the Certification Bodies (CBs).
Particular attention is given to auditing top management and the evaluation of process effectiveness (PEARs), customer satisfaction and supplier performance by adopting the P-D-C-A cycle.
downloadable (pdf) Delegate Manual is included with this e-Learning course
Course details
Throughout the e-Learning course you will need to make reference to your personal copy of a relevant sector-specific standard (or ISO 9001). No other standards/guidance documents are required.
The course is delivered as an online e-Learning module via TEC's learning management system (LMS) platform. Within this e-Learning course, the following sections are covered:
Auditing-related terms, definitions and methodologies
What is an internal audit?
Explanation of audit-related terms
Test: explanation of audit-related terms
Understanding interested parties and their requirements
Guidelines and Standards relating to auditing
Relationship between elements of the QMS
Understanding QMS processes
Test: identifying types of QMS process
Examples of QMS process types
Visualizing QMS processes – sequence and interaction
Test: evaluating an organization’s description of its QMS processes and their sequence and interaction
QMS business benefits
Understanding the organization and its context
Test: Organization purpose, strategic direction & scope
Audit questions focused on purpose, strategic direction & scope
Benefits of a formal QMS
Test: identifying the benefits of a formal QMS
QMS documentation
AS9100 QMS documentation requirements
Policy ~ Processes ~ Procedures
Identifying ISO 9001 need for documented information
Test: identifying ISO 9001 need for documented information
Determination of the processes needed for the QMS
Test: defining policy, processes & procedures
Auditing using a 'process-based' approach
Deriving process-based audit questions from applicable audit criteria
Deriving audit questions from audit criteria
Test: deriving audit questions from audit criteria
Turtle diagram – visualization tool for process-based QMS internal auditing
Test: identifying the ‘elements’ of a Turtle diagram
Deriving process-based audit questions from Turtle diagram ‘limbs’
Test: mapping audit questions to Turtle diagram 'limbs'
Content and structure of ISO 9001 referring to the P-D-C-A cycle
ISO 9001 content: clauses and requirements
ISO 9001 structure: referring to the P-D-C-A cycle
Test: Locating requirements for OPERATION, SUPPORT and ANCILLARY processes
Understanding and auditing the ‘effectiveness’ of a QMS
Auditing QMS ‘effectiveness’
Requirements for QMS ‘performance’
Test: locating specific requirements for monitoring
Auditing process effectiveness – the ‘PEM’
Conducting an effectiveness audit
Test: scoring process effectiveness – the ‘PEAR’
Auditing conformity of a QMS
Understanding ‘conformity’ with QMS requirements
Test: locating ISO 9001 requirements for auditing purposes
Requirements for OPERATION processes
Test: locating ISO 9001 clauses applicable to OPERATION processes
Test: auditing MRB actions with customer-supplied nonconforming product
Requirements for SUPPORT processes
Test: locating ISO 9001 applicable to SUPPORT processes
Requirements for ANCILLARY processes
Test: locating ISO 9001 applicable to ANCILLARY processes
Auditing performance (P-D-C-A)
Quality objectives define QMS ‘performance’
Test: understanding quality objectives
Auditing quality objectives and the P-D-C-A cycle
Test: auditing customer satisfaction
Test: auditing supplier performance
Auditing risk-based thinking
Understanding/auditing risk-based thinking
Auditing risk-based thinking – “things to consider” ~ ISO 9001 clauses
Exercise: auditing risk-based thinking – “things to consider” ~ ISO 9001 clauses
Identifying and auditing risk sources and related methodologies
Test: operation process risks and things to look for
Audit planning
Audit planning considerations
Identifying ‘audit trails’
Test: establishing an internal audit plan
Different audit methods
Test: identifying different audit methods
Auditing the planning of an internal audit program
Guidance for estimating adequate time to conduct a full internal audit program
Test: estimating the time to conduct a full QMS internal audit
Justifying an audit program
Test: auditing the internal audit program
Planning and conducting a remote audit
Creating an audit work document
Creating an audit work document – format and contents
Personal assignment: creating an audit work document
Creating an audit work document from a Turtle diagram
You’re now ready to undertake an internal audit!
Conducting an opening meeting
Purpose of an opening meeting
Agenda items for an opening meeting
Personal assignment: creating an opening meeting agenda
Conducting an opening meeting
Test: opening meeting dos & don'ts
Performing the internal audit
The ‘evidence-based approach’ to auditing
Audit sample size determination
Test: choosing an appropriate sample focus (operators)
Test: choosing an appropriate sample criteria (POs – purchase orders)
Test: choosing an appropriate sample size (FAIRs – First Article Inspection Reports)
Managing interviews and recording evidence
Format and style of audit questions
Test: turning closed questions into open questions
Building rapport with the auditee
Auditing top management ~ “don’t be intimidated!”
Personal assignment: auditing top management and management review*
Collecting, evaluating, and recording objective evidence
Audit process summary – auditor & auditee activities
Test: dealing with auditee disagreements
Evaluating audit evidence and creating effective NCRs
Criteria for determining nonconformities
Reporting nonconformity using a nonconformity report (NCR)
Test: sections of the 'NCR Template'
Recording multiple instances of nonconformities on a single NCR
Test 1: identifying the applicable clause and formulating an effective NCR
Test 2: identifying the applicable clause and formulating a effective NCR
What if there’s insufficient evidence to determine – conformity? Or nonconformity?
Grading NCRs
Test: grading NCRs (minor/MAJOR)
The ‘mock’ audit (scenarios)
Evaluating simulated audit scenarios
Test 1: Simulated audit scenario – risk-based thinking
Test 2: Simulated audit scenario – corrective action process
Test 3: Simulated audit scenario – job descriptions
Preparing for, and presenting, a closing meeting
Reviewing the audit findings and preparing conclusions
Conducting closing meeting
Personal assignment: creating a closing meeting agenda
Reporting the audit results
Audit report purpose and content
CB audit report contents
Test: Key items in the internal audit report
Conducting audit follow-up
Reminder: correction vs. corrective action
Responsibility for corrective actions
Test: NCR terminology and actions
Verifying the effectiveness of corrections and corrective actions
Test: verification of actions/corrective actions
Auditor selection, competence, and personal qualities
Responsibility for the internal audit program
Auditor competence – methodology and sector/discipline
Auditor competence – methodology
Auditor competence – sector/discipline
Selection of people for internal auditors
Quiz: identifying internal ‘auditor qualities’
Each section of this e-learning course incorporates Tests and Personal assignments to ensure student understanding. Automated tutor hints/specimen answers are also provided.
On successful completion of the course and its tests/exercises, you can download your Training Certificate immediately.
Qualifications & benefits
The benefits of e-learning are numerous; not only are they extremely cost-effective but they provide students with convenience and flexibility as they embark on their learning journey.
The Training Certificate can be downloaded immediately on completion
You can complete your training whenever and wherever you want, and at your own pace – without the pressure of a written examination!
Learners check their own knowledge/skills with structured Test/Personal assignments as-they go with Exercises/Quizzes
Companies do not have to tie-up entire teams at the same time as is the case with conventional classroom-based training.